Medical Device product development (5 cr)
Code: 5251003-3002
General information
Enrollment
02.05.2023 - 06.09.2023
Timing
23.08.2023 - 30.11.2023
Number of ECTS credits allocated
5 op
Mode of delivery
Contact teaching
Unit
Engineering and Business
Teaching languages
- Finnish
Degree programmes
Teachers
- Sari Airenne
Teacher in charge
Sari Airenne
Groups
-
MKEMIK21
-
MKEMIS20
- 06.09.2023 10:00 - 12:00, Lääkinnällisen laitteen tuotekehitys 5251003-3002
- 20.09.2023 09:15 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3002
- 04.10.2023 09:15 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3002
- 08.11.2023 09:00 - 11:00, Lääkinnällisen laitteen tuotekehitys 5251003-3002
Objective
After finishing the course the student is capable of:
- Is familiar with the regulation and legislation that guide the development of medical devices
- Knows the standards that are widely used and understands their role in medical device product development
- Knows risk analysis methods and requirements
- Understands the meaning and impacts of quality systems for product development.
Content
- Legistlation and regulation of medical device development
- Product development standards
- Risk management
- Quality system
- Usability
- Software as a medical device
Evaluation scale
H-5